Ongoing Projects

HOME > R&D Pipeline > Current status > Ongoing Projects

KDDF-201904-34 Preclinical study of IMC-002, a monoclonal antibody targeting human CD47(Oncology, Protein) [2019-08-29]

PRINT
Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

The goal of this study is to be ready for IND submission to US FDA for Phase 1 clinical study. During the course of the project, we will complete GLP tox study and produce clinical supply in GMP facility with high quality standard. Additional preclinical studies to help us understand more about the biology and biomarkers will conducted as well. Achieving the milestone of IND submission is the first step in our efforts to bring innovative new drug to patients. This will also help us engage co-development partners.

Unmet Medical Need & Target Patients

Colorectal cancer (CRC) is one of the top leading causes of cancer-related deaths in OECD countries. Despite recent advances in science, patients with advanced metastatic colorectal cancer (mCRC) have limited therapeutic options, such as chemo- and targeted therapy. These therapies often result in a failure of the treatments due to non-selective toxicity and drug resistance. In addition, clinical benefit of immunotherapies such as PD-(L)1 blockade is limited to only a subset of patients with specific molecular profile such as mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) (about 15%). Thus, there is a high unmet medical need for new therapeutic agents.  

Status

- Preclinical evaluation of efficacy and safety: completed

- GMP DS and DP productions and stability studies: ongoing

- GLP toxicology study in cynomolgus monkeys: ongoing

IND preparation and CTD documentation: ongoing

Intellectual Property

- In the process of PCT national phase entry

- Registered with the USPTO

Competitive Advantages

- Comparable efficacy preclinically: tumor growth suppression in mouse models

- Potentially superior safety profile: minimal binding to RBCs or platelets in vitro and safe hematological profile in cynomolgus monkeys

Contact & Company Overview

Related Project

Related Project
list
Update to 2013 © KOREA DRUG DEVELOPMENT FUND. ALL RIGHTS RESERVED. QR Code